PLUSOPTIX A12C User manual

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Mobile Pediatric Autorefractor
“plusoptiX A12C”
“plusoptiX A12R”
User Manual
Release: 2015-10-16
Plusoptix GmbH
Neumeyerstrasse 48
90411 Nuremberg
Germany
www.plusoptix.eu
Englisch

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Please read this user manual before the use of the device! It explains the functions
of the device. Once the device has been switched on, additional information can
be called up by touching the blue "i" button on screen. This additional information
describes the individual screenshots in detail.
Contents
1Use According to Purpose and Responsibility of the Operator..................................4
2Commissioning the Device .......................................................................................6
2.1Checking the scope of delivery.................................................................................6
2.2 Learning about the device........................................................................................7
2.3 Inserting and charging the rechargeable batteries....................................................9
2.4 Switching the device on and off..............................................................................10
2.5 Screen displays and help texts...............................................................................11
3Performing Measurements......................................................................................12
3.1 Environmental considerations ................................................................................12
3.2 Preparing for a measurement.................................................................................13
3.3 Entering patient data (only plusoptiX A12C)...........................................................14
3.4 Starting a measurement and positioning the camera..............................................17
3.5 Checking and documenting measurement results..................................................20
3.6 Perform next measurement....................................................................................25
4Practical Tips..........................................................................................................26
4.1 Handling clues........................................................................................................26
4.1.1 Adjust settings........................................................................................................26
4.1.2 Customize basic settings........................................................................................27
4.1.3 Set-up screen lock (only plusoptiX A12C)...............................................................28
4.1.4 Activate WLAN (only plusoptiX A12C) ....................................................................29
4.1.5 Connect to EMR (only plusoptiX A12C)..................................................................33
4.1.5.1 Transferring data in CSV format (only plusoptiX A12C) ..........................................33
4.1.5.2 Transferring data in GDT format (only plusoptiX A12C)..........................................35
4.1.6 Export data (only plusoptiX A12C)..........................................................................37
4.1.7 Import patient data (only plusoptiX A12C)...............................................................39
4.1.8 Retrieve patients from database (only plusoptiX A12C)..........................................40
4.1.9 Save and print a measurement report.....................................................................41
4.1.10 Compatible printers and network printing................................................................42
4.1.11 SD card and USB interfaces...................................................................................44
4.1.12 Mini-USB interface..................................................................................................45
4.1.13 Download Software Updates ..................................................................................45
4.1.14 External mouse or keyboard...................................................................................49
4.2 Trouble-shooting guide...........................................................................................50
4.2.1 Trouble-shooting when switching device on............................................................50
4.2.2 Malfunctions when using touch screen ...................................................................50
4.2.3 Error messages when performing a measurement..................................................52
5Maintenance, Calibration, Servicing and Warranty..................................................60
6Technical specifications..........................................................................................61
6.1 Measurements .......................................................................................................61
6.2 Interfaces and standards........................................................................................61
6.3 Power supply and rechargeable batteries...............................................................61
6.4 Ambient conditions for operation and storage.........................................................62
6.5 Size and weight with and without cardboard box....................................................62
6.6 Guidance and manufacturer´s declaration –electromagnetic emissions/ immunity 62
7plusoptiX P12 (optional label printer) ......................................................................64

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Table of figures
Figure 1: Device in cardboard box (plusoptiX A12C)............................................................. 6
Figure 2: Front view of the device (plusoptiX A12C).............................................................. 7
Figure 3: Rear view of the device (plusoptiX A12C)............................................................... 8
Figure 4: Battery compartment view of the device (plusoptiX A12C)...................................... 9
Figure 5: Switching between a screen and the help text.......................................................11
Figure 6: Measuring environment.........................................................................................12
Figure 7: Overview of patient data input ...............................................................................14
Figure 8: Holding the camera and operating the shutter.......................................................17
Figure 9: Aligning the device ................................................................................................17
Figure 10: Recognizing correct measurement distance........................................................18
Figure 11: Overview of measurement result pages...............................................................20
Figure 12: Example of a CSV table ......................................................................................39
Figure 13: Retrieving patients from the database .................................................................40
Figure 14: Measurement report (plusoptiX A12C).................................................................41
Figure 15: Self-adhesive label sample..................................................................................43
Figure 16: Software Update via WLAN.................................................................................47
Figure 17 : Software Update via Mini-USB-cable..................................................................48
Figure 18: Top of plusoptiX P12...........................................................................................64
Figure 19: Bottom of plusoptiX P12......................................................................................65
Figure 20: Open cover and insert paper...............................................................................66
Figure 21: Cleaning the plusoptiX P12 .................................................................................67
Table of screenshots
Screenshot 1: Setting date and time.....................................................................................10
Screenshot 2: Start screen (plusoptiX A12C) .......................................................................13
Screenshot 3: Entering the date of birth ...............................................................................15
Screenshot 4: Entering a first name......................................................................................16
Screenshot 5: Check measurement result............................................................................22
Screenshot 6: Review video screen......................................................................................23
Screenshot 7: Review database entries screen....................................................................24
Screenshot 8: Printing or deleting measurements from database entry................................24
Screenshot 9: Settings overview ..........................................................................................26
Screenshot 10: Basic settings ..............................................................................................27
Screenshot 11: Setting up screen locking.............................................................................28
Screenshot 12: Activating WLAN..........................................................................................29
Screenshot 13: List of active WLAN connections..................................................................30
Screenshot 14: WLAN network without password ................................................................31
Screenshot 15: Enter password for WLAN connection .........................................................31
Screenshot 16: Active WLAN connection .............................................................................32
Screenshot 17: WLAN error messages ................................................................................32
Screenshot 18: CSV settings for EMR integration ................................................................33
Screenshot 19: GDT settings for EMR integration................................................................35
Screenshot 20: Start screen with an active connection to EMR............................................36
Screenshot 21: Saving a backup copy..................................................................................37
Screenshot 22: Generate a report ........................................................................................38
Screenshot 23 : Downloading Software Update ...................................................................46
Screenshot 24: Measurement result page after a "Measurement cancellation" ....................52

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0123
1 Use According to Purpose and Responsibility of the Operator
Please observe the directions in this user manual. In doing so, you will avoid risks and obtain
correct measurement results. The symbols used have the following meanings:
Read this user manual.
Warning notes are designated using this warning symbol.
Mobile Pediatric Autorefractor "plusoptiX A12C" and "plusoptiX A12R" comply with
the specifications of Guideline 2007/47/EG for medical devices.
Mobile Pediatric Autorefractor "plusoptiX A12C" and "plusoptiX A12R" comply with
the specifications of an application part of type B in EN 60601-1.
Only connect Mobile Pediatric Autorefractor "plusoptiX A12C" and "plusoptiX
A12R" to the supplied medical power adapter MES30B-3P1J.
On/Off button (pressure-operated)
The device can be stored and transported at temperatures from 0°C to +50°C
(32°F to 122°F). A temperature between +10°C and +50°C (50°F to 122°F) with
non-condensing air humidity between 20% and 80% is required for operation.
Do not discard the device in household rubbish. Please send the device to
Plusoptix (Plusoptix GmbH, Neumeyerstrasse 46, 90411 Nuremberg, Germany)
for environmentally friendly disposal. Plusoptix will reimburse you the costs for
return of the device.
0°C
+50°C
12V

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Use according to purpose
Mobile Pediatric Autorefractor "plusoptiX A12C" and "plusoptiX A12R" measure the sphere,
cylinder, axis, gaze and pupil diameter in both eyes simultaneously (binocular) in a non-dilated
pupil (miosis). These measurement values are used to calculate gaze asymmetry and inter
pupillary distance.
Anisometropia can only be detected in miosis reliably by means of a binocular refraction
measurement. In this regard, it is irrelevant whether the child accommodates during
measurement, as the refraction differential of both eyes remains constant, despite
accommodation.
The spherical measurement values take into account +1.00 dpt to compensate for the
accommodation on the camera at a distance of one meter. Manual correction is not required.
Note:
The interpretation of the measurement values for recommending therapy is
reserved exclusively for the eye care professional.
Note:
The measurement values may not be used directly for the prescription of glasses
or contact lenses.
Responsibility of the operator
- The operator must ensure that only trained users operate the device.
- At a minimum, the training must consist of reading this user manual and instruction in the
use of the device. A user already trained can perform instruction in the use of the device. In
addition, training is offered by Plusoptix and authorized Plusoptix distributors.
- The operator is responsible for ensuring that external devices connected to Mobile Pediatric
Autorefractor "plusoptiX A12C", "plusoptiX A12R" respectively, complies with the EN
60601-1 and EN 60601-1-1 norms together with the device.
- The operator is responsible for ensuring that in the case of servicing or a warranty claim,
Mobile Pediatric Autorefractor "plusoptiX A12C", "plusoptiX A12R" respectively, is only
opened by Plusoptix or an authorized Plusoptix distributor. Opening the device exposes you
to a risk of an invisible electric shock. In addition, the device warranty becomes null and
void, as does the approval as a medical device.

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2 Commissioning the Device
Thank you for purchasing a Mobile Pediatric Autorefractor "plusoptiX A12C", "plusoptiX A12R"
respectively. Plusoptix is the world leader in the development, production and distribution of
medical devices for pediatric ophthalmic examination. Please contact us should you have
further questions after reading the user manual.
2.1 Checking the scope of delivery
The device is supplied in a cardboard box with foam padding that protects the device from
damage. If the device packaging shows signs of damage at the time of delivery, please inform
the seller of the device immediately.
Figure 1: Device in cardboard box (plusoptiX A12C)
Please check that the contents of the packaging are complete at time of delivery. The scope of
delivery includes:
- User Manual for plusoptiX A12
- Mobile Pediatric Autorefractor "plusoptiX A12C" or "plusoptiX A12R"
- Medical power adapter MES30B-3P1J
- 110V/230V power cord (in compartment under the "plusoptiX A12C" or "plusoptiX A12R")
- 6 x rechargeable AA batteries
- SD card (inserted into device)
Optional accessories:
- +3,00dpt. lenses for accommodation test
- Carrying case for plusoptiX A12
- Wireless label printer “plusoptiX P12” for plusoptiX A12
If the delivery is incomplete, please inform the seller of the device immediately.
6 x AA batteries
110V/230V
power cord
Medical power
adapter
plusoptiX A12C
or
plusoptiX A12R
SD card
+3,00dpt. lenses
(optional)

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2.2 Learning about the device
During a measurement, the device records a series of images. To attract the attention of the
child during the measurement, the device plays a "warble" sound. The speaker required for
this is located behind the vertical slits on the front side of the device.
The camera lens and the LEDs required for illuminating the images are located behind the
black protective shield with the stylized face. This face is also used as a fixation aid.
Note:
If a child is not looking at the camera lens in the middle behind the hexagon during
the measurement, this can lead to a cancellation of the measurement or incorrect
measured values of the visual symmetry. Therefore do not use any other external
fixation aids!
Note:
To prevent the protective shield from becoming dirty, we recommend that you do
not touch it. If the protective shield does become dirty, read chapter 5
"Maintenance, Calibration, Servicing and Warranty" for cleaning instructions.
Speaker
Protective
shield
with face
Camera lens
behind
hexagonal nose
Figure 2: Front view of the device (plusoptiX A12C)

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Attention:
If you need to put the device on its rear side, e.g. to insert or replace the
rechargeable batteries, please place a soft cloth under the device.
plusoptiX A12C has a 5.7 inch screen with capacitive touch sensor located on the rear side of
the device. To activate one of the functions displayed on the screen, all you need to do is
gently touch the screen. The screen and touch sensor are protected from damage behind a
thin glass shield.
plusoptiX A12R has a 4.3 inch screen with resistive touch sensor located on the rear side of
the device. To call up a function displayed on the monitor screen, it is sufficient to tap the
screen with the tip of your finger or with your finger nail. Screen and touch sensor are
protected behind a thin transparent plastic cover.
Two green buttons are visible –the On/Off button (on the right side below the screen), and the
Shutter (on the handle to the right, next to the screen). Chapters 2.4 "Switching the device on
and off" and 3.4 "Starting a measurement and positioning the camera" deal with the functions
of these buttons.
The device has three interfaces –USB, Mini-USB and SD card –which are located in the
center below the screen. Chapters 4.1.11 "SD card and USB interfaces" and 4.1.12 "Mini-USB
interface" explain how to use these interfaces.
Note:
All interfaces are mounted upside down. This means that all media (i.e. USB flash
drives, Mini-USB plugs and SD cards) must be connected with the upper side
facing down.
The left lower edge contains the connection for the 12V charging cable of the medical power
adapter.
Screen
Shutter
On/Off button
Mini USB
SD card
12V input
USB
Figure 3: Rear view of the device (plusoptiX A12C)

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2.3 Inserting and charging the rechargeable batteries
Figure 4: Battery compartment view of the device (plusoptiX A12C)
Attention:
If you need to put the device on its rear side, e.g. to insert or replace the
rechargeable batteries, please place a soft cloth under the device.
To insert the batteries, please put the device on a level working surface on its rear side.
Attention:
If you insert batteries other than those supplied, you should exclusively use
rechargeable Nickel Metal Hydride NiMH/AA HR6 batteries with a capacity of at
least 1900 mAh and a quick-charge rate of min. 1 A.
Now remove the battery compartment cover using a 1-cent coin, and insert the supplied
rechargeable batteries.
Note:
When inserting rechargeable batteries, please ensure that the contacts are located
on the correct side.
Note:
The type plate with the serial number (S/N 120xS-xxx-xxxx xxxx) is located under
the battery compartment. If you contact us regarding extended service or warranty
questions, please remember to always quote the serial number of your device. The
S/N number helps us to answer your question quickly.
Type plate
Battery
compartment

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After inserting the rechargeable batteries, close the battery compartment cover and place the
device in front of you. Now connect the medical power adapter with its power cable to the wall
socket and check whether voltage is present (green light diode at the top of the medical power
adapter lights up). Then connect the 12V charging cable of the medical power adapter to the
device.
The inserted rechargeable batteries will now be charged automatically. The charging time of
the batteries depends on the charge level of the batteries. The maximum battery charging time
is 3 hours for the supplied rechargeable batteries.
2.4 Switching the device on and off
To switch on the device, briefly press the On/Off button. The screen switches on immediately
and the device is booted. The device is ready for use after approx. 25 seconds. After inserting
the batteries, the date and time settings page is displayed on the screen.
The time and date format selected is highlighted in color (1). Set the current date and time by
touching the orange arrows (2 or 3). Use Checkmark button (4) to confirm your entries. You
can change the date and time as well as the display formats at a later stage in Settings (5)
(see chapter 4.1.2 "Customize basic settings").
Note:
If the device is not used for 30 seconds, the screen switches off automatically
(stand-by mode). Touch the screen to reactivate it. If the device is not used for 5
minutes, the device switches-off completely. To switch on again, you need to press
the On/Off button. These two time windows can be individually adjusted in Settings
(5) (see chapter 4.1.2 "Customize basic settings").
To switch off the device, briefly press the On/Off button. The screen switches off immediately
and the device is shut down. If the screen does not switch off, press and hold the On/Off
button until the screen switches off.
1) 2) 3) 4) 5)
Buttons for
time format
Buttons for
date format
Screenshot 1: Setting date and time

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2.5 Screen displays and help texts
All screen displays are designed in the same manner. The Header is located at the top, the
Information section in the center, and the Navigation bar at the bottom.
The header contains:
- the date and time at the left
- the WLAN- (1) and battery status (2) at the right
The WLAN information (1) is only displayed if the WLAN is activated in the Settings. This
function is only available for the plusoptiX A12C. The battery status symbol (2) flashes
when the 12V charging cable is connected and the rechargeable batteries are charged.
- a warning symbol (3), which appears when the rechargeable batteries need to be charged
or the WLAN-reception is interrupted.
In the Navigation Bar active buttons are displayed in color and inactive buttons are displayed
in gray. They include:
- the button with the tools (4),to reach the Settings
- the button with the lock (5), to lock the screen.
This is only displayed when the screen lock is activated in the Settings.
- the button with the green tick (6), to confirm and to save and
- the button for Cancel (7), which cancels without saving.
- the blue information button (8), to open a Help screen.
The Help screen provides an explanation of the buttons in the respective screen view. To
save space, the buttons are replaced by consecutive numbers in the text (as shown here).
At the bottom of the Help screen it is shown which buttons the numbers represent. All
buttons that are displayed in the Help screen are inactive. They are only displayed in color
for illustration purposes.
1) 2) 3) 4) 5) 6) 7) 8)
Information
section
Navigation bar
Buttons
explained in the
help text
Help text
Header
Figure 5: Switching between a screen and the help text

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3 Performing Measurements
Mobile Pediatric Autorefractors "plusoptiX A12C", "plusoptiX A12R" respectively, measures
both eyes simultaneously (binocular) in 0.5 seconds at a distance of one meter (3.3 feet).
Therefore even small children with a short attention span can be measured starting at the age
six months. The simultaneous measurement of both eyes also enables a reliable comparison
of the measurement values of both eyes.
3.1 Environmental considerations
The device uses infrared light to perform measurements. The same infrared light is part of
sunlight and emitted by all incandescent light sources such as light bulbs and halogen spots.
This infrared light is invisible to the human eye and nonhazardous. To obtain accurate
measurements it is important to avoid interfering infrared ambient light in the examination
room. Curtains, blinds or shutters should be closed to exclude sunlight. Switch off all heat-
emitting light sources. However, examination room does not need to be dark. Cold light
sources such as energy saving lamps or neon tubes do not affect measurement results.
To be able to perform a measurement, the child must look at the device. Ensure that the child
is sitting straight and does turn his head across the shoulder. The child's knees and nose must
point towards the camera.
The attentiveness of small children is attracted by playing a special "warble" sound on the
device. However, this works only if the child is not distracted by other persons or objects in the
examination room. Ensure that you close the door to the examination room and avoid activities
that divert the child's attention such as walking around or snapping your fingers. Do not use
additional fixation aids!
The attention span of small children is extremely short. Take advantage of the fact that the
examination room is new to the child. An unusual "warble" sound in this unfamiliar
environment always evokes interest. Enter the patient data into the device before calling the
child into the examination room or after completing the measurement. Avoid protracted
information exchange with parents before the measurement.
1 meter measuring
distance
At eye level
See chapter 4.2
No direct sunlight
See chapter 3.5
Pupil diameter
Minimum 4 mm
Maximum 8 mm
Figure 6: Measuring environment

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3.2 Preparing for a measurement
After setting date and time, the start screen is displayed every time the device is switched on.
Screenshot 2: Start screen (plusoptiX A12C)
Buttons (1) and (2) are highlighted in orange to show that a binocular measurement is being
performed. To perform a monocular measurement, touch buttons (1) or (2). Buttons (3) and (4)
are not shown by plusoptiX A12R.
You can start a anonymous measurement by pressing the Shutter (see chapter 3.4 "Starting a
measurement and positioning the camera").
The plusoptiX A12C possesses a patient database. To enter new patient data (see chapter 3.3
"Entering patient data"), or to call up patient data that has already been saved (see chapter
4.1.8 "Retrieve patients from database"), touch button (3) to move to patient data entry.
1) 2) 3) 4)

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3.3 Entering patient data (only plusoptiX A12C)
To be able to uniquely identify a patient in the database, you need to enter either date of birth,
first name and last name, or an ID number. As an option, examination location and/or contact
information can also be saved in the database (shown with a dotted line in the figure below).
Note:
Pressing the Shutter will start a measurement only, once the patient data has been
entered completely.
You must enter either:
First name + Last name
or
ID number
Entries of date of birth, examination location and contact information are always
optional.
Data entry with ID number
Data entry with first name and last name
Figure 7: Overview of patient data input

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You can enter the date of birth in any form you wish. Touch button (1) to enter the year of
birth, button (2) to enter the month of birth and button (3) to enter the day of birth.
Screenshot 3: Entering the date of birth
After entering the date of birth, you will see a green checkmark (4) as confirmation on the tab.
You have to enter first name and last name or a patient ID number next. This additional
information is necessary to be able to uniquely identify the patient in the database at a later
stage. Simply touch the next tab (5) to move to the next input.
1) 2) 3) 4) 5)

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Use the screen keypad to enter the patient data. Touch:
- the Caps Lock key (1) to switch back and forth between lower- and upper case typing
- the SYM key (2) to insert special characters
- the Backspace key (3) to delete the last character.
Please read chapter 4.1.14 "External mouse or keyboard" if you prefer this option for entering
data.
Screenshot 4: Entering a first name
Once all necessary patient data has been entered, that is, either date of birth and first name
and last name, or date of birth and patient ID, the Checkmark button (4) in the navigation bar
is activated.
You can now either perform a measurement by pressing the Shutter or save the patient data
without performing a measurement. To save the data, simply touch the Checkmark button (4).
1) 2) 3) 4)

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3.4 Starting a measurement and positioning the camera
Hold the device as you would hold a tablet PC and press the Shutter with your right thumb.
Place the device approximately 1.2 meters (4 feet) away from the child at eye level. Although
the measurement distance is one meter (3.3 feet), a degree of practice is required to estimate
this distance. It is easier to hold the device a little further away at the start of a measurement
and then to move it slowly towards the child.
Note:
The screen is fixed at a 45° angle to the camera axis. Tilt your wrists downwards to
align the camera.
Pressing the Shutter will start the camera and play back a "warble" sound. You can now see
the camera image on screen.
Figure 8: Holding the camera and operating the shutter
Figure 9: Aligning the device

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Align camera so that both eyes can be seen on the screen. Then slowly move towards patient
until camera picture on screen is in clear focus. In the beginning the pupils are framed with
white boxes (i.e. the picture is blurred), then by red circles and finally by green circles. Stop
moving once a green line is plotted in between both pupils and a second “warble” sound can
be heard. The measurement starts at this point in time automatically.
A "ping" sound signals that the measurement is complete. In addition to the camera image, the
measurement results are now also displayed on screen.
The picture is blurred. The head of the patient is seen almost completely, because the
measurement distance is too big. Move the device towards the patient until the picture is in
clear focus (see next picture).
The picture is blurred. The eyes are close to the edge of the screen, because the
measurement distance is too small. Move the device away from the patient until the picture
is in clear focus (see previous picture).
The picture is in clear focus. Both pupils are framed by a green circle, the line between the
pupils appears in green and an additional "warble" sound can be heard. The device is now
one meter from the child, and the measurement begins automatically. This second "warble"
sound ensures that the child continues to look at the camera during the measurement.
Refrain from moving the device, and wait until the measurement is complete.
Figure 10: Recognizing correct measurement distance

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If you do not obtain measurement results, check whether the following measurement
prerequisites are met:
a) Measurement distance is correct:
Measurement distance must be in between 95 cm (3.1 feet) and 105 cm (3.9 feet). Check
whether the camera image on screen is in focus. You should be able to see individual hairs
of eyelashes and eyebrows on screen.
b) Patient is looking at the camera lens:
The device and the patient's eyes must be aligned with one another. The patient must be
looking at the hexagonal nose in the camera face. Therefore avoid additional fixation aids.
Check whether green dots are plotted in Gaze charts.
c) Both pupils of the patient can be seen completely:
Both pupils must not be covered by eyelids, eyelashes, eyebrows or long hair, for example.
Check whether you can see both pupils completely on screen and that both are encircled in
green.
d) Pupil sizes are between 4 and 8 mm:
Both pupils must have a diameter in between 4 and 8 mm.
Note:
If a red error message is displayed, please read chapter 4.2.3 “Error messages
when performing a measurement”.

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3.5 Checking and documenting measurement results
Screen size is limited and therefore measurement results are presented on two (plusoptiX
A12R), three screens (plusoptiX A12C) respectively, for better readability. These three
measurement result screens are:
Check measurement results screen
Review video screen
Review database entries screen (nur plusoptiX A12C)
Note:
To exit these three measurement result screens, i.e. to return to the Start screen
and to perform another measurement, you have to press the Shutter.
Touch orange arrows (1) and (2) located in Navigation bar to toggle in between measurement
result screens. An orange dot in between the arrows (1) and (2) indicates which of the two,
three respectively, measurement result screens is displayed.
If a anonymous measurement was performed, the measuring report can be saved manually by
touching the printer button (3).
After touching the printer button (3) the patient data entry screen is displayed by plusoptiX
A12C (see chapter 3.3 “Entering patient data (only plusoptiX A12C)”). PlusoptiX A12R
displays a input field instead. The filled in data are saved by touching the green checkmark (4).
PlusoptiX A12C saves the filled in data in the patient database, too.
1) 2) 3) 4)
Check measurement results screen
Review video screen
Review database entries screen
(only plusoptiX A12C)
Figure 11: Overview of measurement result pages